A STUDY OF CHEMOTHERAPY FOLLOWED BY RADIOTHERAPY IN BORDERLINE RESECTABLE PANCREATIC CANCER(BRPC) AND LOCALLY ADVANCED PANCREATIC CANCER (LAPC)

A PROSPECTIVE STUDY OF CHEMOTHERAPY FOLLOWED BY STEREOTACTIC BODY RADIATION THERAPY(SBRT) IN BORDERLINE RESECTABLE PANCREATIC CANCER(BRPC) AND LOCALLY ADVANCED PANCREATIC CANCER (LAPC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037538

Enrollment

Registered

2021-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified

Interventions

Intervention1: SBRT ARM: Patients receiving 3 cycles of chemotherapy (modified FOLFIRINOX/Gemcitabine nab-paclitaxel/ Gemcitabine based chemotherapy) will be re staged after 2 weeks of chemotherapy an

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed adenocarcinoma of pancreas 2. Determined borderline resectable or locally advanced. 3. Induction modified FOLFIRINOX/ Gemcitabine based combination/ Gemcitabine-nab paclitaxel up to 3cycles. 4. Stable or disease regression on re staging scans. 5. Tumour diameter 7 cm 6. Satisfying the radiation normal tissue constraints as per protocol. 7. ECOG 0,1,2 8. Patients must have acceptable organ and marrow function: 9. Ability to understand and willingness to sign an informed consent.

Exclusion criteria

Exclusion criteria: 1.Tumor in growth into stomach or duodenum 2.Metastatic disease 3. Patients who have had prior radiotherapy to upper abdomen/liver. 4. Patients who have received prior chemotherapy for pancreatic cancer, other than Gemcitabine/ nab paclitaxel/ FOLFIRINOX 5. Uncontrolled intercurrent illness including but not limited to ongoing iOS active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,or psychiatric illness/ social situations that would limit compliance with study requirements.

Design outcomes

Primary

Measure	Time frame
To compare resectability rates and resection status (R0) in borderline respectable pancreatic cancer (BRPC) between SBRT and chemo radiation. To determine local progression free survival (LPFS) in locally advanced pancreatic cancer (LAPC)Timepoint: 3months after completion of treatment	—

Secondary

Measure	Time frame
To evaluate acute and late toxicity To evaluate quality of life of patients before and after treatment. Comparison of doses to target volume and organs at risk between plans made on breath hol CT and free breathing CT. Analysis of peripheral immune profile, neutrophil to lymphocyte ratio , platelet to lymphocyte ratio, CD4/CD8 counts.Timepoint: Before chemotherapy, before start of SBRT, 4weeks after SBRT and 3months post SBRT	—

Measure

Time frame

To evaluate acute and late toxicity To evaluate quality of life of patients before and after treatment. Comparison of doses to target volume and organs at risk between plans made on breath hol CT and free breathing CT. Analysis of peripheral immune profile, neutrophil to lymphocyte ratio , platelet to lymphocyte ratio, CD4/CD8 counts.Timepoint: Before chemotherapy, before start of SBRT, 4weeks after SBRT and 3months post SBRT

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Countries

India

Contacts

Public ContactDR VANDANA THAKUR

PGIMER

thakurvandana445@gmail.com8894155445

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026